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The prophylactic effect of Hydroxychloroquine on Novel Corona virus (COVID-19) in health care providers

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History
# Registration date Revision Id
2 2020-08-18, 1399/05/28 147896
1 2020-05-04, 1399/02/15 132583
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  • Protocol summary

    A randomized clinical trial, controlled by 140 people (two equal groups (70 people)) from the health care staff (in Arak city) who are dealing with patients. One group will be given hydroxychloroquine and the other group will be given routine care.
    A randomized clinical trial, controlled by 90 people (two equal groups (45 people)) from the health care staff (in Arak city) who are dealing with patients. One group will be given hydroxychloroquine and the other group will be given routine care.
    کارآزمایی بالینی تصادفی شده، کنترل‌دار روی 140 نفر (دو گروه مساوی (70 نفر))از کادر بهداشتی درمانی شهر اراک که در مواجهه با بیماران هستند. به یک گروه دارو هیدروکسی کلروکین و به گروه دیگر مراقبت های روتین ارایه خواهد شد.
    کارآزمایی بالینی تصادفی شده، کنترل‌دار روی 90 نفر (دو گروه مساوی 45 نفری) از کادر بهداشتی درمانی شهر اراک که در مواجهه با بیماران هستند. به یک گروه دارو هیدروکسی کلروکین و به گروه دیگر مراقبت های روتین ارایه خواهد شد.

  • General information

    140
    90
    2020-06-14, 1399/03/25
    2020-07-15, 1399/04/25
    empty
    Protocol Change
    empty
    تغییر پروتکل اجرایی
    In order to allocate participants to two groups, the permuted balanced block randomization method with blocks size of 4 will be used, and by using this method, concealment will also be guaranteed. To generate the random sequence, Sealed Envelope online site will be used.
    This study will conducted in two referral hospitals for COVID-19 in Arak. For logistical reasons, we will to randomly allocate the staff of one hospital in the intervention group and the other hospital in the control group.
    برای تخصیص افراد به دو گروه از روش تصادفی سازی بلوکی با سایز بلوک های 4 تایی استفاده خواهد شد که به واسطه استفاده از این روش، پنهان سازی (Concealment) نیز رعایت خواهد شد. برای تولید توالی تصادفی سازی از سایت آنلاین Sealed Envelope استفاده خواهد شد.
    این مطالعه در دو بیمارستان سانتر COVID-19 در اراک انجام خواهد شد. به دلایل لجستیکی و راحتی انجام کار، کارکنان یک بیمارستان در گروه مداخله و بیمارستان بعدی در گروه کنترل قرار خواهند گرفت.

  • Recruitment centers

    #1
    Name of recruitment center - English: Valiasr Hospital
    Name of recruitment center - Persian: بیمارستان ولیعصر
    Full name of responsible person - English: Dr. Parviz Rad
    Full name of responsible person - Persian: دکتر پرویز راد
    Street address - English: khorram Ave, valiasr hospital
    Street address - Persian: خیابان خرم، بیمارستان ولیعصر
    City - English: arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 2367816985
    Phone: +98 86 3222 0099
    Fax:
    Email: r.parvizrad@arakmu.ac.ir
    Web page address:
    Name of recruitment center - English: Valiasr Hospital
    Name of recruitment center - Persian: بیمارستان ولیعصر
    Full name of responsible person - English: Dr. Ramin Parvizrad
    Full name of responsible person - Persian: دکتر رامین پرویز راد
    Street address - English: Khorram Ave, valiasr hospital
    Street address - Persian: خیابان خرم، بیمارستان ولیعصر
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 2367816985
    Phone: +98 86 3222 0099
    Fax:
    Email: r.parvizrad@arakmu.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Khansari Hospital
    Name of recruitment center - Persian: بیمارستان خوانساری
    Full name of responsible person - English: Dr. Parviz Rad
    Full name of responsible person - Persian: دکتر پرویز راد
    Street address - English: khorram Ave, valiasr hospital
    Street address - Persian: خیابان حرم، بیمارستان ولیعصر
    City - English: arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 8962456325
    Phone: +98 86 3222 0099
    Fax:
    Email: r.parvizrad@arakmu.ac.ir
    Web page address:
    Name of recruitment center - English: Khansari Hospital
    Name of recruitment center - Persian: بیمارستان خوانساری
    Full name of responsible person - English: Dr. Ramin Parvizrad
    Full name of responsible person - Persian: دکتر رامین پرویز راد
    Street address - English: Khorram Ave, valiasr hospital
    Street address - Persian: خیابان خرم، بیمارستان ولیعصر
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 8962456325
    Phone: +98 86 3222 0099
    Fax:
    Email: r.parvizrad@arakmu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr.parviz rad
    Full name of responsible person - Persian: دکتر پرویز راد
    Street address - English: Khorram Ave., Valiasr Hospita
    Street address - Persian: خیابان خرم، بیمارستان ولیعصر
    City - English: arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 8695325412
    Phone: +98 86 3222 0099
    Fax:
    Email: r.parvizrad@arakmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Alirza Kamali
    Full name of responsible person - Persian: دکتر علیرضا کمالی
    Street address - English: Khorram Ave., Valiasr Hospita
    Street address - Persian: خیابان خرم، بیمارستان ولیعصر
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 8695325412
    Phone: +98 86 3222 0099
    Fax:
    Email: alikamaliir@yahoo.com
    Web page address:

Protocol summary

Study aim
Determination of the prophylactic effect of hydroxychloroquine on the prevention of covid19 in medical staff in Arak
Design
A randomized clinical trial, controlled by 90 people (two equal groups (45 people)) from the health care staff (in Arak city) who are dealing with patients. One group will be given hydroxychloroquine and the other group will be given routine care.
Settings and conduct
At the beginning of the study, the conditions will be fully explained to the individuals, the conditions of the drugs will be explained, and people will also be told that they are randomly assigned to one of the two groups and will be reassured. Their information will remain confidential to the researcher and they can be removed from the study at any stage of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1. Have a consent to participate in the study 2. People working in medical centers in Arak 3. Lack of sensitivity to hydroxychloroquine 4. Lack of G6PD disease 5. Lack of porphyria 6. Lack of breastfeeding 7. Not getting pregnant 8. Lack of diabetes, kidney and liver disease, and skin problems Exclusion Criteria: 1- Lack of desire to continue the study 2- Having major side effects
Intervention groups
Hydroxychloroquine is a drug that was originally used to prevent and treat malaria. These drugs are known as anti-malarial drugs, and since the ocular side effects of hydroxychloroquine are less than those of chloroquine, most hydroxychloroquine is now prescribed to treat rheumatological diseases. In this study, participants in the intervention group would receive 400 mg of hydroxychloroquine for eight weeks, and those in the control group would receive routine care for diseases. It should be noted that both groups will receive routine care.
Main outcome variables
The incidence of the disease and its severity will be compared between the two groups

General information

Reason for update
Protocol Change
Acronym
IRCT registration information
IRCT registration number: IRCT20151222025660N2
Registration date: 2020-05-04, 1399/02/15
Registration timing: registered_while_recruiting

Last update: 2020-08-20, 1399/05/30
Update count: 1
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Ramin Parvizrad
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 863222003
Email address
r.parvizrad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of Hydroxychloroquine on Novel Corona virus (COVID-19) in health care providers
Public title
The prophylactic effect of Hydroxychloroquine on Novel Corona virus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
consent to participate in the study People working in medical centers in Arak city Lack of sensitivity to hydroxychloroquine Lack of G6PD Lack of porphyria No breastfeeding No pregnancy Lack of diabetes, kidney , liver and skin disease
Exclusion criteria:
Lack of desire to continue studying Having major side effects from medication
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
This study will conducted in two referral hospitals for COVID-19 in Arak. For logistical reasons, we will to randomly allocate the staff of one hospital in the intervention group and the other hospital in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
arak
Province
Markazi
Postal code
6258794163
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.ARAKMU.REC.1398.345

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
The number of confirmed cases
Timepoint
At the beginning and 2 months after the start of the study
Method of measurement
Checklist

2

Description
Serum CRP levels and cellular immunity (cd8 / cd4 ratio) are assessed at the beginning and end of the study for all subjects.
Timepoint
At the beginning and 2 months after the start of the study
Method of measurement
Checklist

3

Description
the two groups will also be examined in terms of disease severity (need for intubation, ICU hospitalization) and absolute lymphocyte count.
Timepoint
At the beginning and 2 months after the start of the study
Method of measurement
Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive 400 mg of hydroxychloroquine (Tehran Darou, Iran) a week for eight weeks and also this group will receive routine care for Corona's new disease.
Category
Prevention

2

Description
Control group: They will receive routine care for Corona's new disease
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr. Ramin Parvizrad
Street address
Khorram Ave, valiasr hospital
City
Arak
Province
Markazi
Postal code
2367816985
Phone
+98 86 3222 0099
Email
r.parvizrad@arakmu.ac.ir

2

Recruitment center
Name of recruitment center
Khansari Hospital
Full name of responsible person
Dr. Ramin Parvizrad
Street address
Khorram Ave, valiasr hospital
City
Arak
Province
Markazi
Postal code
8962456325
Phone
+98 86 3222 0099
Email
r.parvizrad@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alirza Kamali
Street address
Khorram Ave., Valiasr Hospita
City
Arak
Province
Markazi
Postal code
8695325412
Phone
+98 86 3222 0099
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Ramin Parvizrad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khorram Ave, valiasr hospital
City
Arak
Province
Markazi
Postal code
8962534125
Phone
+98 86 3222 0099
Email
r.parvizrad@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Ramin Parvizrad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khorram Ave, valiasr hospital
City
Arak
Province
Markazi
Postal code
8965236512
Phone
+98 86 3222 0099
Email
r.parvizrad@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Ramin Parvizrad
Position
Assistante Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khorram Ave, valiasr hospital
City
Arak
Province
Markazi
Postal code
8962236515
Phone
+98 86 3222 0099
Email
r.parvizrad@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared
When the data will become available and for how long
After completing the study
To whom data/document is available
Public
Under which criteria data/document could be used
There are no other conditions
From where data/document is obtainable
Phone number: 09127760893
What processes are involved for a request to access data/document
1 month after coordination with the executor whose number was mentioned above
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